Endobronchial Silicone Valve for Patients With Emphysema
NCT ID: NCT07097896
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
147 participants
INTERVENTIONAL
2025-07-31
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema
NCT01457833
Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures
NCT01902732
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
NCT02763631
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
NCT05717192
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
NCT01102712
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This clinical trial included two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) with optimal medical therapy. The 'Control' group will receive Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that the ESV has similar efficacy and safety to EBV in treating patients with severe emphysema.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ESV and Optimal Medical Management
This study arm will undergo ESV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
ESV
This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV and Optimal Medical Management
This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV
This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ESV
This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV
This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nonsmoking for 4 months prior to screening interview
* BMI less than 35 kg/m2
* Stable on current medication regimen
* Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
* Residual Volume less than 175% predicted (determined by body plethysmography)
* Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion Criteria
* Had two or more hospitalizations over the last year for pneumonia
* Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
* Had a heart attack or congestive heart failure within the last 6 months
* Have heart arrhythmia
* Is alpha-1 antitrypsin deficient
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Cardiotech Medical Technology CO., LTD
UNKNOWN
China-Japan Friendship Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gang Hou
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-ESV-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.